Elecsys HE4 Chinese Reference Value Study

Aim of this study is to provide specimens for establishing reference values of HE4 in an apparently healthy Chinese population using the Roche Elecsys HE4 assay tested on variety of Elecsys and cobas brand immunoassay analyzers. This reference range will be compared to population of subjects who have signs and symptoms of various benign and malignant diseases, including ovarian cancer. This reference range will also be compared to the levels of HE4 in individual subjects who have been diagnosed with ovarian cancer and are being followed longitudinally for recurrence or progression of their disease.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

China PLA General Hospital, Beijing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(all cohorts):

appropriate clinical data
normal appearance of sample
minimum 0.5 ml volume available

Exclusion criteria

(all cohorts):

< 18 years of age
insufficient volume
insufficient clinical information
> 3 freeze/thaw cycles of samples
Stored or shipped at > 0°C
Icteric, lipemic, hemolytic, substantial particulates

Treatment and study plan

Primary outcomes

Establish reference in Chinese population

Time frame: October 2012 - March 2013

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

A Multi-center Reference Value Study of Elecsys HE4 in Chinese Population

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Nov 30, 2012
Registry last updated: Jul 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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